510(k) K913500 ยท GCJ Laparoscope, General & Plastic Surgery
CHERRY SPONGE
| Applicant | O.R. Concepts, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Sep 25, 1991 |
| Received | Aug 7, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913500
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2024 | ASPEN SURGICAL Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101 Completed |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.